在儿童患者中使用阿普拉克隆尼丁眼药滴的系统性毒性
Paula Gish1, Ivone Kim1, Rachna Kapoor1
1Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA ophthalmology
|November 6, 2025
概括
局部阿普拉克隆尼丁眼药滴在儿科患者中可能引起严重的全身毒性,包括中枢神经系统和呼吸系统抑郁. 医疗保健提供者应监测这些风险,特别是婴儿,当使用该药物非标签时.
科学领域:
- 眼科医生 眼科 眼科
- 儿科药理学 儿科药理学
- 药物监督 药物监督 药物监督
背景情况:
- 阿普拉克隆尼丁是一种局部的α-2上腺激动剂,用于儿童患者的非标注,用于诊断无性病,通常是为了排除霍纳综合征.
- 对于儿童的眼科阿普拉克隆尼丁使用造成的全身毒性并没有得到很好的描述.
研究的目的:
- 识别和描述在接受apraclonidine眼药滴的儿科患者中出现系统性毒性的营销后报告.
- 评估apraclonidine在儿科患者中的安全性.
主要方法:
- 对美国食品和药物管理局的不良事件报告系统和医学文献进行了全面的搜索.
- 分析了使用阿布拉克洛尼丁眼药滴的儿科患者系统性不良事件的病例报告.
- 数据包括人口统计,使用理由,剂量,延迟,干预措施和结果.
主要成果:
- 21名儿科患者 (平均年龄6个月) 经历了系统性不良事件.
- 最常见的事件是长时间的昏迷和不反应 (81%) 和心肺呼吸系统损害 (38%),包括呼吸暂停和缺氧.
- 一岁以下的婴儿受到影响最大,经常接受诊断目的的阿普拉克隆尼丁.
结论:
- 儿科使用阿普拉克洛尼丁眼药滴带有中枢神经系统和呼吸抑制的风险.
- 临床医生必须警潜在的系统性影响,并准备为儿科患者,特别是婴儿的治疗做好准备.
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